AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES— 510(k) K963610

Name: FDA 510(k) clearance K963610
Creator: U.S. Food and Drug Administration
Published: 1996-11-27

Substantially Equivalent

A.L.I. Technologies, Inc.

FDA 510(k) clearance K963610 for AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES, Substantially Equivalent on 1996-11-27. Applicant: A.L.I. Technologies, Inc.. Device class: 2.

Clearance details

Applicant: A.L.I. Technologies, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1996-09-10
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond,Bc, CA

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K003762 — ALI 3D TOOL MODULE FOR MEDICAL IMAGES2001-02-28

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.